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NCT Number: NCT05557929

Cardiopulmonary Exercise Testing Parameters' Variability in Hemodialysis Patients.

Chronic kidney disease (CKD), especially end-stage kidney disease (ESKD), is associated with increased risk for cardiovascular events and all-cause mortality. Exercise intolerance as well as reduced cardiovascular reserve are extremely common in patients with CKD. Cardiopulmonary exercise testing (CPET) is a non-invasive, dynamic technique that provides an integrative evaluation of cardiovascular, pulmonary, neuropsychological and metabolic function during maximal or submaximal exercise, allowing the evaluation of functional reserves of these systems. CPET is currently considered to be the gold-standard for identifying exercise limitation and differentiating its causes. It has been widely used in several medical fields for risk stratification, clinical evaluation and other applications. However, the use of CPET in assessment of exercise intolerance in everyday nephrology practice is limited. Hence, this is the first study possible differences in CPET's parameters during long and short interdialytic intervals in hemodialysis patients.

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Key information

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hippokration General Hospital of Thessaloniki, Aristotle University of Thessaloniki

Thessaloniki, Thessalonikis, 54642, Greece

About this study

This is an observational study with a cross-over design performed in the Department of Nephrology and the Third Department of Cardiology in Hippokration Hospital of Thessaloniki in Greece. For the purposes of this study, hemodialysis patients fulfilling the inclusion/exclusion criteria, as well as controls without CKD, were invited to participate. All included patients signed a written informed consent form. The study protocol was approved by the Ethics Committee of the School of Medicine, Aristotle University of Thessaloniki. All procedures and evaluations are performed according to the Declaration of Helsinki 2013 Amendment.

Baseline evaluation includes the recording of demographics and anthropometric characteristics, medical history, concomitant medications and dialysis-related parameters, as well as physical examination and venous blood sampling for routine laboratory tests. Hemodialysis patients will be evaluated at two time points (at the end of the long and at the end of the short interdialytic interval), while controls at one time point. All the participants will undergo spirometry, CPET, cardiac ultrasound, lung ultrasound and bioelectrical impedance analysis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemodialysis patients aged >18 years.
  • Patients with a total duration of hemodialysis >3 months.
  • Patients enrolled in a dialysis program that includes three sessions per week.
  • Hemodialysis patients who are capable of exercising on a cycle ergometer.
  • Hemodialysis patients who are capable of understanding and providing written, signed consent to participate in the study

Exclusion criteria

Absolute and relative contraindications for performing CPET according to the American Thoracic Society (ATS) and the American College of Chest Physicians (ACCP), such as

  • Acute myocardial infarction (3-5 days)
  • Unstable angina
  • Uncontrolled arrhythmias causing symptoms or haemodynamic compromise
  • Syncope
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Symptomatic severe aortic stenosis
  • Uncontrolled heart failure
  • Acute pulmonary embolus or pulmonary infarction
  • Thrombosis of lower extremities
  • Suspected dissecting aneurysm
  • Uncontrolled asthma
  • Pulmonary oedema
  • Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (ie, infection, renal failure, thyrotoxicosis)
  • Mental impairment leading to inability to cooperate
  • Orthopaedic impairment that compromises exercise performance
  • Electrolyte abnormalities
  • Advanced or complicated pregnancy...

Treatment and study plan

Primary outcomes

  1. Difference in VO2peak (ml/min/kg)

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in VO2peak (ml/min/kg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

  2. Difference in VO2peak ((ml/min)

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in VO2peak (ml/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

Secondary outcomes

  1. Difference in Maximum workload (Watt)

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Maximum workload (Watt) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

  2. Difference in VCO2 (ml/min)

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in VCO2 (ml/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

  3. Difference in Heart Rate (bpm)

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Heart Rate (bpm) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

  4. Difference in O2 pulse

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in O2 pulse assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

  5. Difference in VE (L/min)

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in VE (L/min) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

  6. Difference in Tidal Volume, VT (ml)

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Tidal Volume, VT (ml) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

  7. Difference in Respiratory Rate, RR

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Respiratory Rate, RR assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

  8. Difference in PETCO2 (mmHg)

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in PETCO2 (mmHg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

  9. Difference in PETO2 (mmHg)

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in PETO2 (mmHg) assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

  10. Difference in VE/VCO2

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in VE/VCO2 assessed with CPET between long and short Interdialytic Interval in Hemodialysis Patients.

Other outcomes

  1. Difference in Forced expiratory volume in one second, FEV1

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Forced expiratory volume in one second, FEV1 assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.

  2. Difference in Forced vital capacity, FVC

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Forced vital capacity, FVC assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.

  3. Difference in FEV1/FVC

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in FEV1/FVC assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.

  4. Difference in Total lung capacity, TLC

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Total lung capacity, TLC assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.

  5. Difference in Residual volume, RV

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Residual volume, RV assessed with Spirometry between long and short Interdialytic Interval in Hemodialysis Patients.

  6. Difference in Left ventricular mass index, LVMI

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Left ventricular mass index, LVMI assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  7. Difference in Left ventricular end-systolic volume, LVESV

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Left ventricular end-systolic volume, LVESV assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  8. Difference in Left ventricular end-diastolic volume, LVEDV

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Left ventricular end-diastolic volume, LVEDV assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  9. Difference in Global longitudinal strain, GLS

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Global longitudinal strain, GLS assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  10. Difference in Right ventricular free wall - RVFW GLS

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Right ventricular free wall - RVFW GLS assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  11. Difference in Tricuspid annular plane systolic excursion - TAPSE

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Tricuspid annular plane systolic excursion - TAPSE assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  12. Difference in Tissue Doppler imaging - TDI S

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Tissue Doppler imaging - TDI S assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  13. Difference in Pulmonary artery systolic pressure - PASP

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Pulmonary artery systolic pressure - PASP assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  14. Difference in E/e

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in E/e assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  15. Difference in E/A

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in E/A assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  16. Difference in Left atrial volume index - LAVi

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Left atrial volume index - LAVi assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  17. Difference in Left ventricular ejection fraction, LVEF

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Left ventricular ejection fraction, LVEF assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  18. Difference in Diameter of the inferior vena cava, IVC

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Diameter of the inferior vena cava, IVC assessed with Heart Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  19. Difference in B- lines' number

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in B- lines' number assessed with Lung Ultrasound between long and short Interdialytic Interval in Hemodialysis Patients.

  20. Difference in Total body water, TBW

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Total body water, TBW assessed with Bioelectrical impedance analysis between long and short Interdialytic Interval in Hemodialysis Patients.

  21. Difference in Fat-free mass, FFM

    Time frame: Two-week time frame between the study evaluation time points (before dialysis session after the long interdialytic interval versus before dialysis session after the short interdialytic interval)

    Difference in Fat-free mass, FFM assessed with Bioelectrical impedance analysis between long and short Interdialytic Interval in Hemodialysis Patients.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Cardiopulmonary Exercise Testing Parameters' Variability During Long and Short Interdialytic Intervals in Hemodialysis Patients.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2022
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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